Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-28 @ 6:02 PM
Study NCT ID:
NCT01391403
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2011-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artemisinin With Risperidone for First-Episode and Drug-Naive Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031327', 'term': 'artemisinin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-10', 'studyFirstSubmitDate': '2011-07-07', 'studyFirstSubmitQcDate': '2011-07-11', 'lastUpdatePostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': '10 weeks'}], 'secondaryOutcomes': [{'measure': 'the Clinical Global Impression (ICG)', 'timeFrame': '10 weeks'}, {'measure': 'UKU Side Effect Rating Scale', 'timeFrame': '10 weeks'}, {'measure': 'the Simpson-Angus Scale for extrapyramidal side effects (SAS)', 'timeFrame': '10 weeks'}, {'measure': 'The Abnormal Involuntary Movement Scale (AIMS)', 'timeFrame': '10 weeks'}, {'measure': 'the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Risperidone', 'Artemisinin', 'Toxoplasma', 'Immune'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stanleyresearch.org', 'label': 'The Stanley Medical Research Institute (SMRI) is a nonprofit organization supporting research on the causes of, and treatments for, schizophrenia and bipolar disorder. This current study was supported by the SMRI.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of artemisinin plus risperidone in improving symptoms and cognitive disturbances and in Chinese people with schizophrenia. The study addresses the Toxoplasma infection hypothesis of schizophrenia.', 'detailedDescription': 'Evidences of high levels of Toxoplasma gondii antibodies in the serum and the cerebrospinal fluid (CSF) of individuals with schizophrenia have suggested that this organism might be involved in the etiopathogenesis of schizophrenia. The investigators hypothesize that antimicrobial therapy by using an add-on agent together with a well-proven neuroleptic may have favorable effects on a subgroup of schizophrenic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Currently resides in Beijing, China\n* Diagnosis of schizophrenia or schizophreniform disorder\n* Duration of symptoms is no longer than 60 months\n* No history of treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days\n* Current psychotic symptoms are of moderate severity or greater as measured by one of the five psychotic items in the Brief Psychiatric Rating Scale (BPRS)\n\nExclusion Criteria:\n\n* DSM-IV Axis I diagnosis other than schizophrenia or schizophreniform psychosis\n* Documented disease of the central nervous system that might interfere with the trial assessments (e.g., stroke, tumor, Parkinson's disease, Huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic infection)\n* Acute, unstable, and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)\n* A clinically significant echocardiogram (ECG) abnormality in the opinion of the investigator\n* Pregnant or breastfeeding\n* Use of prohibited concomitant therapy\n* History of severe allergy or hypersensitivity\n* Dependence on alcohol or illegal drugs\n* Use of any of the following medications during the trial: antipsychotic medications other than risperidone; psychostimulants; or antidepressants"}, 'identificationModule': {'nctId': 'NCT01391403', 'briefTitle': 'Artemisinin With Risperidone for First-Episode and Drug-Naive Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Beijing HuiLongGuan Hospital'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled Trial of Artemisinin as an Add-on Therapy to Risperidone in the Treatment of Drug-Naive First-Episode Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'SMRI 05T-726'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Artemisinin, anti-toxoplasma', 'description': 'Artemisinin', 'interventionNames': ['Drug: Artemisinin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo looks like the active drug, with the same dose.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Artemisinin', 'type': 'DRUG', 'otherNames': ['Qinghaosu'], 'description': '400 mg/day', 'armGroupLabels': ['Artemisinin, anti-toxoplasma']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '400mg/day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100096', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing HuiLongGuan hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Lian Y Cao, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing HuiLongGuan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing HuiLongGuan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanley Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, the Research Center', 'investigatorFullName': 'Xiang Yang Zhang', 'investigatorAffiliation': 'Beijing HuiLongGuan Hospital'}}}}